Events

Recall of Contour, Contour TS Blood Glucose Test Strips and Bonus Packs

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Bayer Healthcare, LLC.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    59467
  • Event Risk Class
    Class 2
  • Event Number
    Z-3268-2011
  • Event Initiated Date
    2011-08-12
  • Event Date Posted
    2011-09-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-07-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102842
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Glucose dehydrogenase, glucose - Product Code LFR
  • Reason
    All 10- or 25- count glucose test strip vials, either loose vials or found in patient starter kits of contour, contour ts and contour" usb blood glucose meters are being recalled a packaging issue which, under certain conditions, can cause some test strips packaged in some small-count vials to operate outside of us fda-cleared performance specifications and produce a low-bias reading during blood.
  • Action
    Bayer sent an "URGENT DIABETES TEST STRIP RECALL" letter dated August 12, 2011, to its customers with the name of the test strips, sizes recalled, reason for the recall, potential injury, and instructions to discontinue use and return the test strips to Bayer. The recall letter also included a recall response form that was to be faxed back to Bayer at 1-800-876-2243. For questions call Customer Logistics at 1-800-348-2637.

Device

Contour, Contour TS Blood Glucose Test Strips and Bonus Packs
  • Model / Serial
    9545C, 9677, 9678, 9679, 9680, 7151G, 7190, 7183, 9615, 7393, 9591, 9591A 9579, 1802, 6181, 7070A, 9725, 9507C, and 9578.   Contour 125 Count Bonus Pack (includes 2-50 Count and 1-25 Count Vials) the following lot numbers:DW0AC3B32A, DW0AC3B32C, DW0BC3B31A, DW0BC3B31B, DW0BC3D05B, DW0CC3B31A, DW0CC3B31B, DW0GC3B31C, DW0GC3B31D, DW0GC3B31F, DW0HC3B32A, DW9MC3B32D, DW9MC3B32E, DW9MC3B33A, and DW9MC3B33B.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution and Puerto Rico
  • Product Description
    Contour, Contour TS Blood Glucose Test Strips and Bonus Packs || Intended for self-testing by people with diabetes and healthcare professionals to monitor glucose concentrations in whole blood
  • Manufacturer
    Bayer Healthcare, LLC

Manufacturer

Bayer Healthcare, LLC
  • Manufacturer Address
    Bayer Healthcare, LLC, 430 S Beiger Street, Mishawaka IN 46544-3207
  • Manufacturer Parent Company (2017)
    Bayer AG
  • Source
    USFDA